Aseptic filling of sterile drugs remains one of the most challenging processes in biopharmaceutical manufacturing. It requires co-ordination and interaction between personnel, product, equipment and support facilities. At the same time, the formulation of highly potent active pharmaceutical ingredients (HAPIs) is growing due to significant advances in clinical pharmacology and oncology research. Recent industry estimates put more than 40% of all new APIs in this category.
Higher potency APIs have greater effect at a lower concentration than traditional APIs, and the trend towards higher potency is reflected within the biopharmaceutical arena too. The increased potency of sterile products requires evaluation of the manufacturing process from two angles: the high containment requirements for the operator and environment safety; and the aseptic process regulations for the protection of the integrity for the finished sterile product. These are two separate approaches that not many drug manufacturers and process equipment suppliers are able to consider as a whole.
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